On Wednesday, 10 states filed a lawsuit over CMS' vaccine requirement for health care workers—but legal experts have argued that the agency has the legal authority to implement a vaccine mandate. 

The Covid-19 vaccine mandate: Here's what's in CMS' new rule

Background

CMS last week issued an interim final rule requiring most health care facilities that participate in Medicare and Medicaid programs to have their staff fully vaccinated against Covid-19 by Jan. 4, 2022—a rule CMS said was issued to protect both the public and the health care workforce.

Resource library: How health care organizations can navigate vaccine mandates and other issues

Under the interim rule, CMS established a two-phase process for providers and suppliers who participate in Medicare and Medicaid to vaccinate their staff. All eligible staff will be required to receive their first dose of the Covid-19 vaccine by December 5—and must be fully vaccinated against Covid-19 by January 4, 2022.

While the rule applies to all provider and supplier staff, regardless of whether they are patient-facing, CMS said it will not apply to those who work 100% remotely and do not interact with any other staff. CMS estimated the requirement will apply to approximately 76,000 providers and cover over 17 million health care workers across the country. 

Another vaccine mandate lawsuit

According to the New York Times, the lawsuit was filed on Wednesday in the U.S. District Court for the Eastern District of Missouri. In the lawsuit, Missouri—joined by Alaska, Arkansas, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming—challenged CMS' requirement, arguing that it represents an overreach of federal authority.

Specifically, the lawsuit alleges that the rule "imposes an unprecedented federal vaccine mandate on nearly every full-time employee, part-time employee, volunteer, and contractor working at a wide range of health care facilities receiving Medicare or Medicaid funding." The lawsuit adds, "This case illustrates why the police power over compulsory vaccination has always been the province of—and still properly belongs to—the states."

In particular, the lawsuit took issue with how the rule does not allow employees to opt for routine Covid-19 testing instead of vaccination, or grant an exception for those who have previously been infected—exceptions that are included in a related interim final rule recently released by the Occupational Safety and Health Administration (OSHA), which is itself facing legal pushback. (On Saturday, a three-judge panel from the U.S. Court of Appeals for the Fifth Circuit in Louisiana temporarily blocked the OSHA vaccine mandate, saying that a suit against the mandate "g[a]ve cause to believe there are grave statutory and constitutional issues with the mandate.")

The lawsuit also alleges that the CMS rule inflicts harm on the relevant states because it requires state-operated health care facilities to enforce the requirement, which will result in higher overall costs.

Ultimately, the states in the lawsuit contend that states should be in charge of public health issues, and that CMS' regulatory authority does not permit the agency to establish so broad a requirement without authorization from Congress. The lawsuit also states that CMS' justifications for the rule are insufficient, and that CMS is in violation of laws barring federal agencies from controlling the selection or employment duration of people working as health care providers. 

Moreover, according to the lawsuit, the CMS requirement "threatens with job loss millions of health care workers who risked their lives in the early days of the Covid-19 pandemic to care for strangers and friends in their communities" and may "exacerbate an alarming shortage of health care workers, particularly in rural communities, that has already reached a boiling point."

Calling the vaccine mandates an "unprecedented federal overreach," Missouri Attorney General Eric Schmitt (R) said in a statement that the mandate was "unconstitutional and unlawful." He echoed concerns that the rule "could exacerbate health care staffing shortages to the point of collapse, especially in Missouri's rural areas."

What experts have said about the controversial rule

While the states that sued over CMS' rule have argued in the lawsuit that the agency does not have the legal authority to enforce a vaccine mandate, many legal scholars have affirmed CMS' authority to do so, according to Modern Healthcare and the New York Times.

For example, Katrina Pagonis, a lawyer specializing in regulatory issues for Hooper, Lundy & Bookman, said that "CMS has very broad authority to regulate Medicare-certified providers."

Similarly, James Hodge, director of the Center for Public Health Law and Policy at Arizona State University, said CMS has the broad ability to tie policy to the receipt of federal funds, Modern Healthcare reports. And Erin McLaughlin, a health care lawyer for Buchanan, Ingersoll & Rooney, said the rule was "essentially a condition of participation" in Medicare and Medicaid. 

While a CMS spokesperson said the agency could not comment on the pending litigation, the agency released a statement that said "there is no question that staff in any health care setting who remain unvaccinated pose both direct and indirect threats to patient safety and population health."

Ultimately, CMS plans to work primarily with health care facilities to implement and enforce the interim rule, the Times reports. According to Chiquita Brooks-LaSure, the administrator for CMS, "Our focus is really on educating providers and getting people to be in compliance." (Goldman, Modern Healthcare, 11/10; Abelson, New York Times, 11/11; Rai, The Hill, 11/10)